BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    HEATED RESPIRATORY HUMIDIFIER

    K Number: K892817 · Decision Dec 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    216
    Applicant Total
    17
    Review Days
    248

    Basic Information

    Device Name
    HEATED RESPIRATORY HUMIDIFIER
    K Number
    K892817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    FISHER & PAYKEL ELECTRONICS LTD.
    Date Received
    April 17, 1989
    Decision Date
    December 21, 1989
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by FISHER & PAYKEL ELECTRONICS LTD.

    K Number Device Name
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